Clearance Summary
STELLA BIO received FDA 510(k) clearance under submission number K210002, sponsored by Egzotech Sp. Z O. O.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2021-10-01.
- Submission: K210002
- Applicant / Sponsor: Egzotech Sp. Z O. O.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2021-10-01
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.